Staff Operations Quality Engineer

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do.

But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.

Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

Position Summary

Staff Operations Quality Engineer provides quality assurance support for all aspects of manufacturing operations, including process quality, QC testing, inspections (incoming, in-process and final), validations, supplier quality, DMR/DHR creation and maintenance and various QMS activities through the operations lifecycle. Furthermore, this role focuses on establishing strategies for quality engineering, inspection & testing, suppliers and supply chain activities to achieve operational excellence.

The role collaborates and builds relationships with cross-functional stakeholders such as Laboratory Operations, Supply Chain, Supplier Quality, Equipment, Facilities, EH&S, Quality Assurance, Quality Control and QMS teams to develop ideas and use cases and industry best practices in the implementation of manufacturing operations in a hybrid (diagnostic/IVD and clinical/CLIA/CAP/LDT) laboratory environment.

Job Responsibilities

• Process and Production Controls: Work closely with laboratory/manufacturing operations and other functions to ensure quality performance of product workflows and associated processes. Capture process knowledge to facilitate subsequent process validation activities.

• Process Monitoring: Continuously monitor and analyze production processes, identifying potential failure modes, risks, and controls, and opportunities for improvement and implementing corrective and preventive actions.

• Process Improvement: Modify methodologies and procedures, ensuring continuous improvement of processes. Employ statistical analysis, and problem-solving techniques to drive product quality improvements, minimize defects, and enhance overall performance.

• NPI/Manufacturing Transfer: Provide quality engineering support to Product Development, Translational Sciences, Design Quality Teams for NPI programs. Support process development and process characterization and ensure the efficient and timely transfer of process knowledge and quality systems knowledge to Laboratory (Manufacturing) Operations. Support the creation of DMR and DHR for new medical device/IVD products.

• Risk Assessment: Partner with Risk Management team to conduct thorough risk assessments, utilizing tools such as FMEAs, to proactively identify and address potential product or process risks.

• QC Inspection and Testing: Support Supply Chain for incoming material, in-process and final product release. Oversee incoming inventory material receiving records, and quality control testing documentation to release the materials for production use. Review, sign-off and release of kit, batch and other manufacturing records to ensure the completeness of DHRs. Support the development of material specification and incoming inspection process including test method development and test method validation. Lead investigations of complaints, non-conforming products and materials to identify root causes and determine appropriate disposition through MRB.

• Supplier Quality: Support supplier quality initiatives to maintain a robust supplier quality program.

• QMS and Change Controls: Support change management activities throughout product life cycle as applicable to Operations (sustaining engineering/value engineering). Support CAPAs, deviations and other QMS activities. Ensure adherence to GDP, GMP, EH&S and other applicable procedures to manufacturing.

• Regulatory Compliance: Drive a customer (internal and external) centric quality culture and maintain compliance to applicable standards, regulations and internal QMS requirements. Support audit prepara